Clinical Trial Manager

What You'll Do

• Review scope of project and resourcing related to Clinical Monitoring with Clinical Project ManagementPlan, schedule, and implement the clinical monitoring aspects of projects
• Define and implement project-specific functional standards, goals, and expectations with Clinical Monitoring team including KPIs, KRIs, QTLs and additional metrics as agreed upon
• Primary point of contact for Clinical Monitoring aspects of designated projects
• Serve as advocate for the Clinical Monitoring team with the client
• Coverage and oversight of daily operations of Clinical Monitoring team, including CRAs and in-house personnel. Ensure assigned CRAs receive therapeutic and project-specific training
• Develop CRA tools and CRA training materials
• Organize and conduct CRA meetings/calls if in project scope
• Audit and track accurate study information related to Clinical Monitoring deliverables
• Oversight of key clinical monitoring metrics, including but not limited to: Visits scheduled per CTMP, Monitoring Visit Reports (MVR) and associated correspondence timelines, Action Items (AI), query resolution, and other quality metrics, to ensure they are met and followed-up on as necessary
• Provide oversight of visit report review and approval, including site issue escalation and resolution; may conduct visit report review and approval depending on team structure
• Manage clinical monitoring related project milestones and proactively address deficiencies
• Oversee the quality and timeliness of clinical data in the eDC per Clinical Trial Monitoring Plan
• Oversee the core clinical portions of the Trial Master File and ensure they are up-to-date and maintained in accordance with SOPs
• Monitor clinical monitoring risk planning and assessment, developing mitigation strategies and associated action plans, issue escalation, and resolution
• Oversee all clinical monitoring/site management related closeout activities
• Mentor CRAs, as needed, on the Clinical Project team to ensure high performance and productivity
• Provide feedback/information on CRA performance as requested by CRA line managers
• As necessary serve as CRA trainer/mentor and accompany CRAs in the field for training visits, assessment/oversight visits, or co-monitoring visits
• Develop successful cross-functional relationships with internal and external team members
• May be required to undertake specific CPM tasks, as agreed with Line Manager
• Ability to understand and oversee CRA timesheets for tracked hours exceeding budgeted hours and escalate to CPM and CRA Line Manager
• Serve as a contact/resource for investigative sites as required
• Conduct on-site or remote monitoring activities as needed, including, but not limited to, Pre-study and Site Initiation Visits during project startup
• Act as the primary monitoring point of contact for sponsors and sites for smaller or single service projects
• Participate in Bid Defense planning and Bid Defense Meetings as requested
• Assist with other duties as assigned

What You'll Bring

• Excellent verbal and written communication skills
• Excellent organizational and time management skills
• Excellent critical thinking and decision-making skills; proactively identify challenges and potential risks
• Excellent collaboration, customer service, and interpersonal skills
• Ability to work independently
• Proficient in use of laptop computer and software systems, including Clinical Trial Management (CTMS), electronic Trial Master File (eTMF), Electronic Data Capture (EDC), Microsoft Excel/PowerPoint/Word, or similar systems
• Ability to understand complex medical terminology and procedures
• Ability to review and explain study budgets to CRA and CMAs
• Expert knowledge of ICH/GCP and all applicable regulatory requirements
• Ability to mentor and provide constructive feedback to lesser experienced
• At least 8 years as CRA or other experience in clinical research deemed pertinent by hiring manager
• Prior proficient performance as Lead CRA for at least 1 year
• Maintained previous role performance KPIs and metrics at fully performing or exceeds level for at least 2 years
• Demonstrated successful performance at Senior CRA level, with at least 4 of the required 8 years as CRA, of experience monitoring complex studies
• Bachelor's Degree or higher in allied health field such as nursing, pharmacy, or health / natural science, or RN with Associate's Degree, or 3-year Nursing Diploma with at least 2 years clinical nursing experience, or equivalent experience as determined by CTI Management and Human Resources
• Experience in conducting clinical research studies in hospital setting, pharmaceutical company or CRO